Machine Learning Assisted Differentiation of Low Acuity Patients at Dispatch (MADLAD)
Primary Purpose
Emergencies
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
openTriage - Alitis algorithm
Sponsored by
About this trial
This is an interventional health services research trial for Emergencies
Eligibility Criteria
Inclusion Criteria:
- Identification of a resource constrained situation by ambulance director (i.e., 2 or more patients awaiting an ambulance response)
- Assigned priority 2A or 2B (Low-priority ambulance response) by dispatch nurse call-taker
- Valid Swedish personal identification number collected at dispatch
- Age >= 18 years
Exclusion Criteria:
- Relevant calls received more than 30 minutes apart
- Logistical factors (eg. the patients' geographical locations) affect the ambulance assignment decision
- On scene risk factors (eg. a patient is outdoors and risks hypothermia) or risk mitigators (eg. healthcare staff already on-scene with a patient) affect the ambulance assignment decision
Sites / Locations
- Västmanland hospital Västerås
- Uppsala University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Calculation of risk assessment score by machine learning algorithm and display of risk assessment information to dispatch nurses. Staff encouraged but not required to comply with suggested ranking.
Ambulance dispatch per standard of care
Outcomes
Primary Outcome Measures
Proportion of RCS where the first available ambulance was dispatched to the patient with the highest National Early Warning Score (NEWS).
NEWS is a widely used and well-validated scoring algorithm based on objective patient vital signs, which are not causally dependent on the outcomes used to train the machine learning models investigated in this study. NEWS values will be based on the first set of vital signs obtained by ambulance nurses upon making contact with the patient. NEWS is measured on a 0-21 scale, with higher values corresponding to patients at higher risk for deterioration.
Secondary Outcome Measures
Difference in composite outcome measure score between patients with immediate vs. delayed response.
This measure investigates a composite score consisting of the outcomes used to train the machine learning models. The composite score is generated by identifying the following patient outcomes and assigning the corresponding weights:
Abnormal intitial Arway/Breathing/Circulation findings by ambulance crew (4) Emergent (lights and sirens) transport to the hospital (2) Provision of prehospital interventions (1) Admission to in-patient care or mortality within 30 days (1)
This results in a score from 0-8, with higher scores representing more
Difference in National Early Warning Score (NEWS) between patients with immediate vs. delayed response.
Per primary outcome
Full Information
NCT ID
NCT04757194
First Posted
February 3, 2021
Last Updated
June 14, 2023
Sponsor
Uppsala University Hospital
Collaborators
Region Västmanland
1. Study Identification
Unique Protocol Identification Number
NCT04757194
Brief Title
Machine Learning Assisted Differentiation of Low Acuity Patients at Dispatch
Acronym
MADLAD
Official Title
Machine Learning Assisted Differentiation of Low Acuity Patients at Dispatch: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University Hospital
Collaborators
Region Västmanland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
BACKGROUND:
At Emergency Medical Dispatch (EMD) centers, Resource Constrained Situations (RCS) where there are more callers requiring an ambulance than there are available ambulances are common. At the EMD centers in Uppsala and Västmanland, patients experiencing these situations are typically assigned a low-priority response, are often elderly, and have non-specific symptoms. Machine learning techniques offer a promising but largely untested approach to assessing risks among these patients.
OBJECTIVES:
To establish whether the provision of machine learning-based risk scores improves the ability of dispatchers to identify patients at high risk for deterioration in RCS.
DESIGN:
Multi-centre, parallel-grouped, randomized, analyst-blinded trial.
POPULATION:
Adult patients contacting the national emergency line (112), assessed by a dispatch nurse in Uppsala or Västmanland as requiring a low-priority ambulance response, and experiencing an RCS.
OUTCOMES:
Primary:
1. Proportion of RCS where the first available ambulance was dispatched to the patient with the highest National Early Warning Score (NEWS) score
Secondary:
Difference in composite risk score consisting of ambulance interventions, emergent transport, hospital admission, intensive care, and mortality between patients receiving immediate vs. delayed ambulance response during RCS.
Difference in NEWS between patients receiving immediate vs. delayed ambulance response during RCS.
INTERVENTION:
A machine learning model will estimate the risk associated with each patient involved in the RCS, and propose a patient to receive the available ambulance. In the intervention arm only, the assessment will be displayed in a user interface integrated into the dispatching system.
TRIAL SIZE:
1500 RCS each consisting of multiple patients randomized 1:1 to control and intervention arms
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Groups of patients experiencing a resource constrained situation randomized 1:1 at time of inclusion to control/intervention arms
Masking
Investigator
Masking Description
Analyst masked to treatment group allocation in final analysis. Outcomes extracted algorithmically from databases.
Allocation
Randomized
Enrollment
2700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Calculation of risk assessment score by machine learning algorithm and display of risk assessment information to dispatch nurses. Staff encouraged but not required to comply with suggested ranking.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Ambulance dispatch per standard of care
Intervention Type
Diagnostic Test
Intervention Name(s)
openTriage - Alitis algorithm
Intervention Description
A machine learning algorithm (Gradient boosting) applied to structured data collected in the Alitis Clinical Decision Support system, patient demographics, and free-text notes.
Primary Outcome Measure Information:
Title
Proportion of RCS where the first available ambulance was dispatched to the patient with the highest National Early Warning Score (NEWS).
Description
NEWS is a widely used and well-validated scoring algorithm based on objective patient vital signs, which are not causally dependent on the outcomes used to train the machine learning models investigated in this study. NEWS values will be based on the first set of vital signs obtained by ambulance nurses upon making contact with the patient. NEWS is measured on a 0-21 scale, with higher values corresponding to patients at higher risk for deterioration.
Time Frame
Upon ambulance response (Within 8 hours of dispatch)
Secondary Outcome Measure Information:
Title
Difference in composite outcome measure score between patients with immediate vs. delayed response.
Description
This measure investigates a composite score consisting of the outcomes used to train the machine learning models. The composite score is generated by identifying the following patient outcomes and assigning the corresponding weights:
Abnormal intitial Arway/Breathing/Circulation findings by ambulance crew (4) Emergent (lights and sirens) transport to the hospital (2) Provision of prehospital interventions (1) Admission to in-patient care or mortality within 30 days (1)
This results in a score from 0-8, with higher scores representing more
Time Frame
Up to 30 days
Title
Difference in National Early Warning Score (NEWS) between patients with immediate vs. delayed response.
Description
Per primary outcome
Time Frame
Upon ambulance response (Within 8 hours of dispatch)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Identification of a resource constrained situation by ambulance director (i.e., 2 or more patients awaiting an ambulance response)
Assigned priority 2A or 2B (Low-priority ambulance response) by dispatch nurse call-taker
Valid Swedish personal identification number collected at dispatch
Age >= 18 years
Exclusion Criteria:
Relevant calls received more than 30 minutes apart
Logistical factors (eg. the patients' geographical locations) affect the ambulance assignment decision
On scene risk factors (eg. a patient is outdoors and risks hypothermia) or risk mitigators (eg. healthcare staff already on-scene with a patient) affect the ambulance assignment decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Blomberg, MD, PhD
Email
hans.blomberg@akademiska.se
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas Spangler, MSc
Email
douglas.spangler@akademiska.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Blomberg, MD, PhD
Organizational Affiliation
Uppsala University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Västmanland hospital Västerås
City
Västerås
State/Province
Västmanland
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lennart Edmark
Email
lennart.edmark@regionvastmanland.se
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Blomberg
Email
hans.blomberg@akademiska.se
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual level data available upon reasonable request to authors after publication
IPD Sharing Time Frame
Upon publication
IPD Sharing Access Criteria
Researchers with ethics board approved research plan
Citations:
PubMed Identifier
31834920
Citation
Spangler D, Hermansson T, Smekal D, Blomberg H. A validation of machine learning-based risk scores in the prehospital setting. PLoS One. 2019 Dec 13;14(12):e0226518. doi: 10.1371/journal.pone.0226518. eCollection 2019.
Results Reference
background
PubMed Identifier
32198303
Citation
Spangler D, Edmark L, Winblad U, Collden-Benneck J, Borg H, Blomberg H. Using trigger tools to identify triage errors by ambulance dispatch nurses in Sweden: an observational study. BMJ Open. 2020 Mar 19;10(3):e035004. doi: 10.1136/bmjopen-2019-035004.
Results Reference
background
Links:
URL
https://github.com/dnspangler/openTriage
Description
Source code for risk assessment tool used in intervention
Learn more about this trial
Machine Learning Assisted Differentiation of Low Acuity Patients at Dispatch
We'll reach out to this number within 24 hrs